The Efficacy and Safety of Fluzoparib Plus Irinotecan as Second-line Treatment in Patients With Homologous Recombination Deficiency (HRD) Metastatic Colorectal Cancer.

NCT05732129 | Unknown Phase 2

• 1 other identifier: 2207257-12
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

Preclinical data support the investigation of PARP inhibitors in other neoplasms exhibiting homologous recombination deficiency (HRD) as monotherapy as well as in combination with chemotherapy. However，in colorectal cancer (CRC), the role of HRD alterations is mostly unknown. This study aims to explore the the Efficacy and Safety of Fluzoparib combined with Irinotecan in the Second-line treatment of HRD alterations metastatic colorectal cancer.

Conditions

Homologous Recombination Deficiency Alterations Metastatic Colorectal Cancer

Keywords

Fluzoparib Plus Irinotecan; Homologous Recombination Deficiency (HRD) Alterations

Outcome Measures

Primary Outcomes (1)

• Objective response rate of Metastatic Colorectal Cancer,inculdthe proportion of patients with complete response or partial response

  using RECIST v 1.1.

  assessed up to 1 year

Secondary Outcomes (3)

• Progression-Free Survival of Metastatic Colorectal Cancer，includ time from enrollment to the first documented disease progression or death due to any cause, whichever occurs first

  assessed up to 1 year

• Overall survival of Metastatic Colorectal Cancer, include time from randomization to death from any cause

  assessed up to 2 year

• The Safety of Fluzoparib Plus Irinotecan as Second-line Treatment in Patients With Homologous Recombination Deficiency (HRD) Metastatic Colorectal Cancer.

  assessed up to 2 year

Study Arms (1)

Fluzoparib plus Irinotecan

EXPERIMENTAL

Patients will receive Fluzoparib combined with Irinotecan treatment protocol, which included irinotecan asintravenous infusion at 180mg/m2 (on day 1) and Fluzoparib 150mg capsules given bid (days 1-7) every 2 weeks .

Drug: Fluzoparib; Drug: Irinotecan

Interventions

Fluzoparib DRUG

150mg,orally, bid (days 1-7) every 2 weeks

Fluzoparib plus Irinotecan

Irinotecan DRUG

30-90min continuous infusion 180mg/m2 Irinotecan on day 1, q2w

Fluzoparib plus Irinotecan

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years；
• Histological or cytological confirmed metastatic colorectal cancer;
• HRD alterations（inclued BRCA1/2、ATM、CDK12、PALB2、Check2、RAD51C、RAD51D etc.）；
• Intolerability toxicity occurs 8 weeks within first-line therapy;
• ECOG PS 0-1;
• Adequate hepatic, renal, heart, and hematologic functions;
• Negative serum pregnancy test at screening for women of childbearing potential;
• Informed consent was signed before the study began.

You may not qualify if:

• Prior treatment with PARPi drugs；
• Symptomatic brain or meningeal metastases；
• Patients have received local radiotherapy within 1 month prior to treatment;
• Patients who had active bleeding or coagulopathy before enrollment, had a tendency to bleed, or were receiving thrombolytic therapy and were considered by the investigator to be ineligible for enrollment;
• Women who are pregnant (with a positive pregnancy test before medication) or breastfeeding;
• Expected survival \<3 months;
• Received other investigational drugs within 4 weeks prior to treatment;
• Patients who had active uncontrollable neurological, mental disease or mental disorder, poor compliance, unable to cooperate and describe the treatment response;
• Allergy to the study drug or any of its excipients;

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Department of Colorectal Surgery Fudan University Shanghai Caner Center

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Kenny-Caffey syndrome, Type 1

Interventions

fluzoparib; Irinotecan

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds

Central Study Contacts

Ye Xu, PhD

CONTACT

+86-21-6417-5590; xu_shirley021@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Chief of Department of Colorectal Surgery

Study Record Dates

• First Submitted: February 8, 2023
• First Posted: February 16, 2023
• Study Start: March 1, 2023
• Primary Completion: November 30, 2023
• Study Completion: December 31, 2023
• Last Updated: February 24, 2023

Record last verified: 2023-02

Locations

CN (1)